Chantix (varenicline) and Zyban (buproprion) Label Change Required To Indicate Serious Mental Health Events.

FDA earlier in may 2008 approved a label change for smoking cessation aid, Chantix but now have released another request for label change. This time it has added Zyban to the list as well. The labeling approval came after an Advisory on Chantix by FDA, which was issued in February 2008.

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

For Immediate Release: July 1, 2009

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for buproprion marketed as the antidepressant Wellbutrin and for generic versions of buproprion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
In addition to the Boxed Warning, the FDA also is requesting more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using these products.

Manufacturers also will be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA’s review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Tags: Chantix, zyban, FDA, FDA Advisory, neuropsychiatric symptoms, quit smoking, buproprion, Wellbutrin, GlaxoSmithKline, Pfizer Inc

Health Advisory On Pfizer's Chantix, FDA Advisory.

The FDA said it is very likely that Pfizer Inc.'s smoking-cessation drug Chantix could be tied to serious psychiatric symptoms, advised the FDA's comment is part of a public health advisory issued Friday that could be found below. The public health advisory highlighted warnings issued last month stating that Chantix users should be monitored for suicidal behavior, depressed mood and other changes in behavior.
Chantix is a tablet taken up to twice daily for 12 weeks to help stop smoking. Chantix was approved in the U.S. in May 2006.

FOR IMMEDIATE RELEASE February 1, 2008

Media Inquiries: Susan Cruzan, 301-827-6242 Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Advisory on Chantix
Agency requests that manufacturer add new safety warnings for smoking cessation drug

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.

Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency's continuing reviews and conclusions warrant.

For more information:
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

tag: public health advisory, FDA Advisory, Chantix,

Chantix Works But Chantix and Sutent Concerns Makes Pfizer Shares Fall

According to this Reuters article Pfizer is paying dearly for otherwise very profitable products. I do not know much about Sutent but I can vouch for Chantix or Champix as it known in Europe. Some one very close to me was able to stop smoking after taking Chantix prescription. He did not even use all the Chantix that was assigned. He was a heavy smoker and have been smoking for over 20 years.
He is still doing fine and refers to decision to give up smoking as one of the best decisions that he took. It has been over a year to date and he is normal as one could be. So how a drug works could be different on every one. I spoke to him just before writing this article.
Pfizer, he is willing to give his and his Doctors testimony if that makes any difference. I usually do not take this stance for drug companies. But witnessing one drug works on some one I know makes me wanting to tell the world that fact.
I am not a doctor, in fact only reason I am doing this site is to report on Consumer products, Drugs and Toys that are recalled. I have no Medical knowledge. So do not take this as an advise. I just wanted to state the facts.

Tags: FDA, DRUGS, Chantix, suicidal ideation